Label: WORM AND PARASITES AQUARIUM CURE PROGRAM FRESH- praziquantel kit

  • NDC Code(s): 86048-001-01, 86048-002-01, 86048-011-01
  • Packager: Prodibio SAS
  • Category: OTC ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 27, 2015

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  • INSTRUCTIONS

  • PRESENTATION

  • SPL UNCLASSIFIED SECTION

    - PRODUCT NAME: Worms & Parasites Fresh

  • - ACTIVE INGREDIENTS

    The vials A and B contain per mL:
    • 40,00 mg of 2-(Cyclohexylcarbonyl)-1,2,3,6,7-11b-hexahydro-4Hpyrazino(2,1a)-isoquinolin-4-one (praziquantel)
    •The BioDigest Start vial contains nitrifying and denitrifying living bacteria that have not been genetically modified.

  • - EXCIPIENTS

    • Purified water
    • Propylene glycol

  • - PHARMACEUTICAL FORM & CONTENTS

    • 3 A vials containing 1.3 mL
    • 2 B vials containing 1.5 mL
    • 1 vial of BioDigest Start containing 1.1 mL

  • - MANUFACTURER

    Vials A and B : product manufactured for PRODIBIO, under Good Manufacture Practices (GMP), by Aquarium Münster Pahlsmeier GmbH, Galgheide 8, D-48291 Telgte, Allemagne

    Vial of BioDigest Start : PRODIBIO 3, Allée des Maraîchers, 13013 Marseille France

  • USAGE

    - THERAPEUTIC INDICATIONS
    Product intended only for treatment of ornamental freshwater fish infested with skin worms (Gyrodactylus), gill worms (Dactylogyrus), or tapeworms (Cestodes). Visible symptoms are fish rubbing against the scenery (to get rid of the parasites) in the case of Gyrodactylus; increased respiration for Dactylogyrus; and weight loss despite normal food intake for Cestodes.

  • - DOSAGE AND DIRECTIONS FOR USE

    Shake each vial well before use. Follow this protocol:

     Aquarium Volume
     Days 60-100L 101-180L
     Day 1Water change:
    - 75% of the volume
    Do not feed the fish
    Vials AAA together    		 Water change:
    - 75% of the volume
    Do not feed the fish
    Vials AAABB together
     Day 2Water change:
    - 50% of the volume
    Feed the fish
    No Treatment    		Water change:
    - 50% of the volume
    Feed the fish
    No Treatment
     Day 3Feed the fish
    No Treatment    		Feed the fish
    No Treatment
     Day 4Feed the fish
    No Treatment    		Feed the fish
    No Treatment
     Day 5Feed the fish
    No Treatment    		Feed the fish
    No Treatment
     Day 6Feed the fish
    No Treatment    		Feed the fish
    No Treatment
     Day 7Do not feed the fish
    Vials BB at the same time    		Feed the fish
    Water change:
    - 50% of the volume
    Add the vial BioDigest Start
     Day 8Water change:
    - 50% of the volume
    Feed the fish
    No Treatment
     Day 9Water change:
    - 50% of the volume
    Feed the fish
    No Treatment
    Add the vial BioDigest Start

    During the treatment, carefully monitor the aquarium. Ensure a good water flow and a good oxygenation. Indeed, in the presence of a large bacterial population (filter, gravel), the use of Worms & Parasites Fresh can lead to significant bacterial growth which will induce over-consumption of oxygen. If the water becomes cloudy due to a sudden increase in the number of bacteria, or if signs of a lack of oxygen appear, do an immediate water change of 50% of the Aquarium Volume.

  • - PRESERVATION

    Keep the vials in the original packaging away from direct sunlight and heat sources.
    Do not use after the expiration date printed on the box and vials.

  • PRECAUTIONS- CONTRAINDICATIONS & INTERACTIONS

    Invertebrates such as snails and shrimps cannot withstand Worms & Parasites Fresh, and must be removed from the aquarium before beginning the treatment.

    - UNWANTED SIDE EFFECTS

    None known. Should you notice any side effects, please let us know (info@prodibio.fr).

  • WARNINGS AND PRECAUTIONS

    Product for ornamental fish only, do not use with fish intended for consumption.

    Keep out of the reach of children.

    For animal treatment only

  • Package Labeling:

    boxcaution

    insert

  • INGREDIENTS AND APPEARANCE
    WORM AND PARASITES AQUARIUM CURE PROGRAM FRESH 
    praziquantel kit
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86048-001
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-001-011 in 1 BOX
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 VIAL, SINGLE-USE 3.9 mL
    Part 22 VIAL, SINGLE-USE 3 mL
    Part 1 of 2
    A VIAL 
    praziquantel solution
    Product Information
    Item Code (Source)NDC:86048-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-002-011.3 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Part 2 of 2
    B VIAL 
    praziquantel solution
    Product Information
    Item Code (Source)NDC:86048-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86048-011-011.5 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2015
    Labeler - Prodibio SAS (647909431)
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